Helicobacter pylori Test

Ref. 800017-1

Self-test for the detection of anti Helicobacter pylori antibodies in whole blood samples

HELICOBACTER PYLORI

Helicobacter pylori is a bacterium, whose ideal habitat is the human gastric mucosa, causing an often asymptomatic infection of the gastrointestinal tract.

Sometimes the presence of this bacterium can cause gastritis and ulcers in the stomach or duodenum. The most common symptoms of these conditions are: burning or pain in the upper abdomen, especially between meals when the stomach is empty, nausea and a sense of fullness, reflux, loss of appetite and weight loss. On the long-term the Helicobacter pylori infection is associated with an increased risk of gastric cancer.

WHO IS THIS TEST FOR?

HELICOBACTER PYLORI TEST is useful for a first screening of an ongoing or a past infection of H. pylori.

This bacterium chronically affects about half of the world’s population and plays an important role in the pathogenesis of chronic gastritis, peptic ulcer, gastric cancer, and mucosal-associated lymphoid tissue lymphoma.

TECH SPECS

HELICOBACTER PYLORI TEST is an immunochromatographic device that detects the presence of anti-Helicobater pylori IgG antibodies in blood samples.

Specificity	84.2%
Sensitivity	95.8%
Accuracy	87%

CONTENT

1 test cassette
1 vial with dropper containing the diluent
2 sterile lancets
1 pipette for blood sampling
1 cleanser gauze
instructions for use

USE PROCEDURE

Draw a blood sample by using the sterile lancet provided;
Collect the sample indicated with the black line by using the capillary pipette provided;
Deposit the collected specimen into the sample well (S) indicated on the test cassette;
Add 2 drops of the diluent and wait 5 minutes before reading the result.

RESULTS INTERPRETATION

Negative	no IgG antibodies against Helicobacter pylori have been detected in the sample or their concentration is below the cut-off of 15 AU/mL.
Positive	IgG antibodies against Helicobacter pylori have been identified in the sample, it is necessary to check a possible exposure to the bacterium with a specialist.

VIDEO INSTRUCTIONS

BIBLIOGRAPHY

1. Mati Moyat, Dominique Velin. Immune responses to Helicobacter pylori infection. World J. Gastroenterol. 2014 may 21; 20(19): 5583-5593IgE.” Journal of Allergy and Clinical Immunology. 2014;133(2):589-91.
2. Khean-Lee Goh, Wah-Kheong Chan, Seiji Shiota and Yoshio Yamaoka. Epidemiology of Helicobacter pylori Infection and Public Health Implications. Helicobacter, 2011 Sep;16(0 1):1-9.
3. Kyichi Adachi, Tomoko Mishiro, Shino Tanaka and Yoshikazu Kinoshita. Analysis of negative result in serum anti-pylori IgG antibody test in cases with gastric mucosal atrophy. J. Clin Biochem Nutr.2016 Sep;59(2):145-148.

F.A.Q.

What happens if the results reading time is not met? 

The test has been carried out correctly when the instructions for use are followed. It includes the reading time and the interpretation of the results shown at the "RESULTS INTERPRETATION" section of the instructions for use. 

How to prove that the test worked correctly? 

A colored line will appear at the control region (C) on the test device, showing that the test performed correctly. The absence of the colored line suggests to repeat the test with a new device and a new sample. 

How to interpret the test if the control and test lines have different intensities? 

The color and intensity of the lines do not affect the interpretation of the result. The test has to be considered positive regardless of the color intensity of the test line (T). 